The Bellingham Herald, September 16, 2010

The controversial approval process the Food and Drug Administration uses for most medical devices has in fact enjoyed an "extraordinary safety record" over the past five years, according to a report commissioned by a medical technology industry group.

The report issued Wednesday by Washington, D.C.-based AdvaMed comes at a time when the regulatory pathway for most medical devices is being studied by new leadership at the FDA, as well as the Institute of Medicine, an independent entity that provides advice to policymakers.

At issue is the FDA's 510k approval process, which is the way approximately 73 percent of medical devices get clearance before being marketed in the United States, often without clinical studies to prove the product is safe and effective in patients. Medical device makers must simply prove a product is "substantially equivalent" to one already on the market.

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